Status:
RECRUITING
Host Immune and Metabolic Determinants of Sexual Conversion in Plasmodium Parasites IMMETASEX
Lead Sponsor:
Institute of Tropical Medicine, Belgium
Collaborating Sponsors:
Instituto Nacional de Saúde, Mozambique
Clinical Research Unit of Nanoro (CRUN), Burkina Faso
Conditions:
Severe Malaria
Uncomplicated Malaria
Eligibility:
All Genders
1+ years
Brief Summary
Understanding the sexual conversion of the malaria parasite is essential to interrupt malaria transmission. A new tool is developed that, based on expression analysis of sexual stage biomarkers, will ...
Detailed Description
Understanding the sexual conversion of the malaria parasite is essential to interrupt malaria transmission. At each replicating cycle within erythrocytes, a proportion of asexual parasites converts in...
Eligibility Criteria
Inclusion
- Age: ≥ 1 year
- Willing and able to provide written informed consent (or assent for minors with written informed consent by parent(s) and/or guardian(s).
- Pilot:
- symptomatic for P. falciparum
- /Travel to P. falciparum endemic area within the last month
- WP1:
- Resident in Nanoro district
- non-symptomatic individuals
- WP2:
- Positive for P. falciparum infection via Rapid Diagnostic Tests (RDT)
- Age: ≥ 1 and ≤ 12 years
- Patients are included when suspected of the following conditions:
- I. Severe malaria by infection with P. falciparum is defined in the presence of P. falciparum asexual parasitemia, and as one or more of the following:
- Impaired consciousness: A Blantyre coma score \< 3 (when patients are ≤ 6 years) or Glasgow coma score \< 10 (when patients are ≥ 6 years).
- Prostration: Generalized weakness so that the person is unable to sit, stand or walk without assistance.
- Multiple convulsions: More than two episodes within 24 hours.
- Clinical manifestation of respiratory distress (e.g., rapid, deep and labored breathing).
- Diagnosis through exclusion: absence of an identified alternative cause.
- II. Uncomplicated malaria by infection with P. falciparum is defined as a patient who presents with lethargic profile (e.g. fever) and a positive parasitological test for P. falciparum, but with no features of severe malaria.
Exclusion
- Delayed developmental status or history of chronic illness
- Participation in another study
- Previous malaria treatment or prophylaxis in the last week
- Inability or unwillingness of the parents or guardians to provide informed consent
- WP1:
- Symptoms of malaria, as defined by presence of fever (body temperature \>37.5 °C or history of fever during the past 48 hours) with a positive RDT (RDT are performed always when there is presence of fever)
- Any plans to leave the study are in the coming 10 days
- WP2:
- Severe anemia (will be determined via clinical examination), since blood samples can hardly be withdrawn, co-morbidities.
- A questionnaire will be used during the clinical assessment that addresses following exclusion criteria:
- x Antimalarial drug treatment or other medication during the past week x If the patient had a meal within 4 hours before admission x Patients with acute meningitis (as clinically evaluated according to the local guidelines) x Patients with developmental delay or history of chronic illness x Vaccination during the past week
Key Trial Info
Start Date :
December 13 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT06064591
Start Date
December 13 2023
End Date
December 1 2026
Last Update
February 1 2024
Active Locations (3)
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1
Institute of Tropical Medicine Antwerp
Antwerp, Belgium, 2000
2
Institut de Recherche en Sciences de la Santé - Clinical Research Unit of Nanoro
Nanoro, Burkina Faso
3
Instituto Nacional de Saúde (INS)
Maputo, Mozambique